BD Insyte Autoguard Winged IV Catheter needle retraction failure recall
Becton Dickinson is recalling BD Insyte Autoguard Winged IV Catheters (Ref. 381533, Lot 4282452) because the catheter needle may be slow to retract or fail to retract entirely.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a malfunction (needle retraction failure) that poses a risk of injury through needlestick or other complications. No illnesses or injuries are reported in the source text, but the hazard involves a risk-of-harm product where injury has not yet been reported, placing it at the High level per the rubric.
Plain-English summary
Becton Dickinson Infusion Therapy Systems, Inc. is recalling BD Insyte Autoguard Winged, Shielded IV Catheters (20 GA x 1.00 in) with Reference number 381533 and Lot number 4282452 due to customer complaints. The catheter needle may be slow to retract or fail to retract.
The recalled product was distributed worldwide and nationally across the United States, as well as to Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, and Vietnam. The recalled lot consisted of 50 units.
If you have the affected product, contact Becton Dickinson Infusion Therapy Systems, Inc. for guidance on return, replacement, or disposal. Do not use the product if you believe it may be affected.
The recalled product
- Product
- REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
- Manufacturer
- Becton Dickinson Infusion Therapy Systems, Inc.
- Category
- Medical Device — IV Catheter
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 4282452/UDI: 382903815333
Distribution
Part of a larger recall action
This product is one of 9 recalled by Becton Dickinson Infusion Therapy Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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